Pre-Meeting Questionnaire

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The Menarini Group seeks your expert insights ahead of the Advisory Board meeting on December 11th and 12th 2025, to generate discussion points on current clinical practice and unmet needs, and to inform subsequent refinement of the strategic positioning, key differentiators, and future development pathway for obicetrapib in Europe. All responses will remain confidential and will be used solely to inform scientific and strategic discussions during the meeting.

We kindly request that you complete this questionnaire by the 21st of November to ensure timely preparation for the upcoming advisory board meeting.


For the purpose of this questionnaire, please refer to the ESC/EAS 2025 Focused Update categories of total cardiovascular risk provided below:
Table
Risk category Definition
Moderate SCORE2/SCORE2-OP ≥2 and <10%; Young patients (T1DM <35 years; T2DM <50 years) with DM <10 years and no other risk factors
High SCORE2/SCORE2-OP ≥10 and <20%; Marked elevated single risk factor, in particular TC >8 mmol/L or LDL-C >4.9 mmol/L or BP ≥180/110 mmHg; FH without other risk factors; Moderate CKD (eGFR 30-59mL/min/1.73 m²); DM without target organ damage, with DM duration ≥10 years or other additional risk factor
Very High ASCVD (clinical/imaging); SCORE2/SCORE2-OP ≥20%; FH with ASCVD or with another major risk factor; Severe CKD (eGFR <30 mL/min/1.73 m²); DM and target organ damage: ≥3 major risk factors; or early onset of T1DM of long duration (>20 years)
Extreme Patients with ASCVD who experience recurrent vascular events while taking maximally tolerated stating-based therapy; Patients with polyvascular (e.g coronary and peripheral) arterial disease
ASCVD, atherosclerotic cardiovascular disease; BP, blood pressure; CKD, chronic kidney disease; DM, diabetes mellitus; eGFR, estimated glomerular filtration rate; FH, familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol; SCORE2, Systematic Coronary Risk Evaluation 2; SCORE2-OP, Systematic Coronary Risk Evaluation 2-Older Persons; T1DM, type 1 DM; T2DM, type 2 DM; TC, total cholesterol.

Respondent details

Section 1: Current Treatment Strategies and Unmet Needs

1. In your experience, what are key reasons patients fail to reach LDL-C targets? (Select all that apply)
2. When escalation is needed, which therapy attributes most influence your treatment choice? (Select up to 3)
Select up to 3 choices.
3. a. In patients with extreme CV risk, when LDL-C targets are not reached despite maximally tolerated statin therapy, what is your typical next therapeutic step? (Select one)
3. a. In patients with extreme CV risk, when LDL-C targets are not reached despite maximally tolerated statin therapy, what is your typical next therapeutic step? (Select one)
b. In patients with very high CV risk, when LDL-C targets are not reached despite maximally tolerated statin therapy, what is your typical next therapeutic step? (Select one)
b. In patients with very high CV risk, when LDL-C targets are not reached despite maximally tolerated statin therapy, what is your typical next therapeutic step? (Select one)
c. In patients with high CV risk, when LDL-C targets are not reached despite maximally tolerated statin therapy, what is your typical next therapeutic step? (Select one)
c. In patients with high CV risk, when LDL-C targets are not reached despite maximally tolerated statin therapy, what is your typical next therapeutic step? (Select one)
d. In patients with moderate CV risk, when LDL-C targets are not reached despite maximally tolerated statin therapy, what is your typical next therapeutic step? (Select one)
d. In patients with moderate CV risk, when LDL-C targets are not reached despite maximally tolerated statin therapy, what is your typical next therapeutic step? (Select one)
4. ESC/EAS 2025 Focused Update now recommends bempedoic acid for (1) patients unable to take statins to achieve LDL-C goals and (class I level B) and (2) as an add-on to maximally tolerated statin ± ezetimibe in high or very high-risk patients (class IIa level C) In light of the ESC/EAS 2025 Focused Update, do you expect your use of bempedoic acid over the next 12 months to…
5. Which lipid or inflammatory markers, beyond LDL-C are most clinically relevant for addressing residual cardiovascular risk? (Select all that apply)

Section 2: Perceptions of obicetrapib and fixed-dose combination of obicetrapib plus ezetimibe

1. Based on the emerging data, what are your initial impressions of obicetrapib in terms of:
a. Efficacy (select one):
b. Safety/tolerability (Select one):
2. Which findings have positively influenced your perception of obicetrapib’s clinical value? (Select up to 5):
Select up to 5 choices.
3. Considering the recognised role of Lp(a) in cardiovascular risk, to what extent does obicetrapib’s effect on Lp(a) positively influence your perception of its clinical value?

Section 3: Obicetrapib expected use in clinical practice

1. a. In which patients would you use obicetrapib after statins on maximum tolerated dose fail to achieve LDL-C targets, and why? (Select all that apply)
2. Given the ESC/EAS 2025 Focused Update recommendations for bempedoic acid and PCSK9 inhibitors, assuming obicetrapib is available, what would be your 1st choice of add-on therapy in patients with:
a. Extreme CV risk
b. Very high CV risk
c. High CV risk
d. Moderate CV risk
e. Statin intolerance (complete or partial)
4. Based on currently available data, what are the main differentiating effects between the therapies below and obicetrapib?
a. Bempedoic acid
Select up to 3 choices.
b. PCSK9-directed therapies, such as:
i. mAbs (evolocumab/alirocumab)
Select up to 3 choices.
ii. siRNA (inclisiran)
Select up to 3 choices.
iii. Emerging oral inhibitors (enlicitide)
Select up to 3 choices.

Section 4: Differentiation and Future Directions

1. What type of data will help with the adaptation of obicetrapib?